U.S. Military Smallpox Vaccination ProgramScience

1. U.S. Military Smallpox Vaccination Program Science – Care – Quality – Confidence Armed Forces Epidemiological Board 17 September 2003 COL John D. Grabenstein, RPh, PhD U.S. Army Medical Command

2. DoD Smallpox Vaccination Policy Announced by President Bush, 13 Dec 02. Vaccinate troops before an attack to ensure they are personally protected and can continue their missions. Stages: Stage 1a: Smallpox Epidemic Response Teams (SERTs). 2,000 to 5,000 people, began mid-Dec 02 Stage 1b: Medical Teams for Hospitals & Large Clinics. 10,000 to 25,000 people, began early Jan 03 Stage 2: Mission-Critical Forces, especially CENTCOM. About 500,000 troops, began early Jan 03

3. DoD Smallpox Vaccination Program as of 11 Sep 03 Response teams, hospital workers, operational forces Screened: 565,000 Vaccinated: 492,716 Primary: 71% Male: 87% Exemption rates vary by location: Personal: 5% to 10% Personal + household: 20% to 30% Take (3 sites): Primary, 3 jabs: 96% Revaccination, 15 jabs: 96% Adverse Events: Expected temporary symptoms. Sick leave: Average: 1.5 d Hospital staff: 3% Primary--5.5% Revax—1.5% Deployed troops: 0.5%

5. Day 6-8, “Take Check,” symptoms since vaccination, n = 526, Jan-Feb 2003 Local itching 60% Muscle ache 21% Feeling lousy 20% Lymph nodes swell 14% Headache 18% Bandage reaction 7.4% Itchy all over 5.5% Fever (subjective) 5.3% Local rash 5.3% Body rash 1.1% Eye infection 0.0% Restricted activity 1.3% Took medication 17% Outpatient visit 0.8% Limited duty 0.0% Missed work 0.2% Hospitalized 0.0% Symptoms After Smallpox Vaccination

8. Screening Before Smallpox Vaccination11 Sep 03 n =4,903

9. DoD Smallpox Vaccination Program as of 11 Sep 03 Noteworthy Events among 490,219 Vaccinees: Encephalitis— 1—recovered Generalized vaccinia— 33, all mild, all recovered Inadvertent infection—Skin: Self—48, Contact—27 Inadvertent infection—Eye: Self—11, Contact— 2 Contact transfer: Family—14, intimate contact—7, friend—8, patient—0 Vaccinia Immune Globulin (VIG) treatments: Burn-1, eye-1 Myo-pericarditis: Suspect—0, probable—54, confirmed—2 Eczema vaccinatum: zero Progressive vaccinia: zero Deaths: Attributed to vaccine: 0 Not attributed to vaccine: 3

10. DoD Smallpox Vaccination Program Myo-pericarditis cases, as of 11 Sep 03 People vaccinated: 492,716 Myo-pericarditis: Suspect—0, probable—54, confirmed—2 Of the first 18 cases: JAMA 2003;289:3283-89 Onset interval: 7 to 19 d. Male: 18/18 Age: 21 to 33 years Primary vaccination: 18/18 Present with chest pain: 18/18 Enzymes elevated: 18/18 ECG—ST changes: 16/18 Echo—abnormal: 10/18 Recover: 18/18, following-up Relative risk: 3.6 for a 30-day interval (95% CI: 3.3, 4.1) Conclusion: Smallpox vaccination appears to increase risk of myo-pericarditis among adult male primary vaccinees.

11. Myo-pericarditis Case Follow-Up Thru 31 Jul 03 52 males, 1 female, aged 21 to 43 years confirmed (1 male; 1 female); probable (51 males) Primary vaccination: 50/53 Incidence: 15.36/100,000 primary vaccinees, Relative risk = 7.1 (6.6, 8.1) 35 (67%) available for comprehensive follow-up, 8 + 6 w. 28 (80%) report complete clinical recoveries 22 normal resting echocardiography 13 normal stress exercise testing 2 (6%) persistent non-specific resting ECG changes 7 (20%) persistent subjective symptoms (eg, chest pain).

12. Early Pregnancy Outcomes Among Women Exposed to Smallpox Vaccine in Pregnancy National Smallpox Vaccine in Pregnancy Registry Margaret Ryan, DoD Birth and Infant Health Registry Jane Seward, Kristin Kenyan, Joseph Mulinare, CDC, and others at DoD and CDC

13. Contact Transfer of Vaccinia Virus as of 11 Sep 03 Dec 02 -- Sep 03, 492,716 people vaccinated Skin—27, Eye— 2 Family—14, adult intimate contacts—7, ‘sport’ partners—6, other friends—2, patient—0 CO (4), TX (4), NC (4), AK (2), CA (2), CT (1), KS (1), LA (1), OH (1), WA (1), WV (1), overseas (7). Viral culture and/or PCR positive: 19 cases; others not tested Incidence rate: 5.9 per 100,000 vaccinees overall or 8.4 per 100,000 primary vaccinees. Historical rate: 2 to 6 per 100,000 primary vaccinations. Today: Less immunity among general population. Conclusion: Principal risk is to people who share the same bed. Second: Failure to use bandages according to instructions.

14. Military Vaccination vis-à-vis Pneumonia

18. Vaccinia Lessons Learned Careful screening reduces adverse events < or = 1960s levels. VIG needed less frequently than expected. Education and screening are rate-limiting steps. 3 or 15 jabs yield high “take” rates. Clinicians ‘alarmed’ by first (maculopapular) rashes they saw in vaccinees; lessened with experience. Secondary spread of vaccinia: greatest risk is to bed partners. Myo-pericarditis is greater risk than anticipated, principally male, primary vaccinees in DoD’s experience.

19. Response to AFEB Evaluation of 18 Feb 03

20. Tools & Resources